Plugging device

Abstract

The utility model relates to a plugging device which comprises a first plugging part and a second plugging part which are connected in the direction of a central axis, and the first plugging part and the second plugging part can elastically contract in the direction of the central axis to clamp a vascular intima. The first plugging part and / or the second plugging part comprises a peripheral section and an avoiding section in the circumferential direction, and the distance from the avoiding section to the central axis is smaller than the distance from the peripheral section to the central axis; the surface of the first plugging part and the surface of the second plugging part comprise outer surfaces deviating from each other, and at least one section of the outer surface of the first plugging part and at least one section of the outer surface of the second plugging part are configured to be elastic extrusion parts bent towards each other from inside to outside in the radial direction. The utility model aims to provide a leak-proof plugging device capable of avoiding branch blood vessels.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to an occluder. Background Art

[0002] Aortic dissection refers to a pathological change in which the blood in the aortic cavity enters the gap between the intima and the media from the tear in the aortic intima, causing the intima and the media to separate. Blood continues to enter the gap between the intima and the media, and the gap expands along the axial and radial directions of the aorta, thereby forming an aortic false lumen. For patients with aortic dissection clinically, a tear in the aortic intima can lead to aortic dissection. If the blood vessels in the aortic dissection rupture, the situation is usually very critical, and hemorrhagic shock may occur, leading to severe lack of tissue perfusion. A tear in the aortic intima is a common cause of aortic dissection. With the development of interventional treatment, patients with aortic dissection can be treated by implanting an occluder.

[0003] If the tear in the aortic intima of the patient is close to the opening of a branch blood vessel, the occluder provided by the relevant technology may partially or completely block the opening of the branch blood vessel, thereby causing blockage of the branch blood vessel and subsequent partial tissue necrosis; in addition, blood flow may pass through the gap of the occluder and enter the inner cavity of the occluder to form a thrombus, thereby causing blockage of the blood vessel. Utility Model Content

[0004] The purpose of the present application is to provide an occluder that is leak-proof and can avoid branch blood vessels.

[0005] The present application provides an occluder, which includes a first sealing portion and a second sealing portion connected along a central axis, wherein the first sealing portion and the second sealing portion can elastically contract along the central axis to clamp the vascular endothelium; the first sealing portion and / or the second sealing portion include a peripheral segment and an avoidance segment in the circumferential direction, wherein a distance from the avoidance segment to the central axis is smaller than a distance from the peripheral segment to the central axis; the surfaces of the first sealing portion and the second sealing portion include outer surfaces that face away from each other, and at least one section of the outer surfaces of the first sealing portion and the second sealing portion along the radial direction from the inside to the outside is configured as an elastic extrusion portion that bends toward each other.

[0006] In some embodiments, the avoidance section is radially concave inwardly in a groove shape, so that a first avoidance groove is formed on the first blocking portion, and a second avoidance groove is formed on the second blocking portion.

[0007] In some embodiments, at least one of the groove surface of the first avoidance groove and the groove surface of the second avoidance groove is a curved surface.

[0008] In some embodiments, at least one of the groove surface of the first avoidance groove and the groove surface of the second avoidance groove is an arc surface, and the axis of the arc surface is parallel to the central axis of the occluder.

[0009] In some embodiments, at least one of the groove surface of the first avoidance groove and the groove surface of the second avoidance groove is a plane or a plurality of connected planes, and the plane is parallel to the central axis of the occluder.

[0010] In some embodiments, the first avoidance groove and the second avoidance groove are offset from each other in the circumferential direction.

[0011] In some embodiments, the avoidance section is planar.

[0012] In some embodiments, the inner surface of the first sealing portion forms a first sealing flange, and the inner surface of the second sealing portion forms a second sealing flange; the first sealing flange and the second sealing flange are used to abut against both sides of the vascular endothelium.

[0013] In some embodiments, the portion on the inner surface of the first sealing portion used to contact the vascular endothelium is called the first clamping surface, and the portion on the inner surface of the second sealing portion used to contact the vascular endothelium is called the second clamping surface, and the first clamping surface and the second clamping surface can be abutted against each other.

[0014] In some embodiments, the portion on the inner surface of the first sealing portion used to contact the vascular endothelium is called the first clamping surface, and the portion on the inner surface of the second sealing portion used to contact the vascular endothelium is called the second clamping surface; a clamping cavity is formed between the first sealing portion and the second sealing portion, and the first clamping surface and the second clamping surface are arranged around the clamping cavity.

[0015] In some embodiments, the occluder also includes an operating component, which includes a first operating member and a second operating member movably mounted on the first operating member, the first sealing portion is arranged at a distal end relative to the second sealing portion, the first operating member is detachably connected to the distal end of the first sealing portion, the second operating member is detachably connected to the proximal end of the second sealing portion, and the distal ends of the first operating member and the second operating member are close to each other so that the first sealing portion and the second sealing portion are abutted against each other.

[0016] In some embodiments, the occluder also includes a locking assembly, which includes a connecting piece and a locking piece, wherein the connecting piece is fixedly connected to the proximal end of the second occluding portion, the proximal end of the connecting piece is detachably connected to the second operating piece, the distal end of the locking piece is connected to the distal end of the first occluding portion, the proximal end of the locking piece is detachably connected to the first operating piece, at least part of the locking piece is elastic, and the locking piece is connected to the connecting piece by elastic deformation to lock the relative positions of the first occluding portion and the second occluding portion.

[0017] In some embodiments, the connector is provided with a receiving inner cavity and a connecting hole connected to the receiving inner cavity, the inner diameter of the receiving inner cavity is larger than the hole diameter of the connecting hole, the locking member includes an elastic positioning portion, the positioning portion can be radially contracted and passed through the connecting hole, and the positioning portion can be radially expanded in the receiving inner cavity, thereby achieving locking of the positioning portion and the connector.

[0018] Beneficial effects: In the occluder provided in the present application, a rupture formed in the vascular endothelium is blocked by clamping the vascular endothelium through the first occluding part and the second occluding part; an additional blood flow channel is formed by the avoidance section to prevent the occluding part from blocking the branch blood vessel, thereby ensuring smooth blood perfusion of the branch blood vessel; an elastic extrusion part applies an elastic extrusion force to the vascular endothelium, thereby enhancing the sealing effect of the two occluding parts on the endothelium, especially the avoidance section on the endothelium, reducing or even preventing blood leakage caused by poor fitting of the occluding part to the vascular endothelium. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solution of the embodiments of the utility model, the drawings required for use in the implementation mode will be briefly introduced below. Obviously, the drawings described below are some implementation modes of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0020] Figure 1 This is a schematic diagram of the structure of one of the blood vessels in the body;

[0021] Figure 2 One embodiment of the present application provides an occluder positioned at Figure 1 Schematic diagram of the structure of the blood vessels shown;

[0022] Figure 3 yes Figure 2 A schematic diagram of the three-dimensional structure of the blocking member;

[0023] Figure 4 yes Figure 3 A top view of the blocking member in FIG.

[0024] Figure 5 yes Figure 4 A cross-sectional view of the blocking member along line BB;

[0025] Figure 6 is a top view of the blocking member provided in Example 2 of the present application;

[0026] Figure 7 yes Figure 6 A cross-sectional view of the plugging member along line CC;

[0027] Figure 8 is a top view of the blocking member provided in Example 3 of the present application;

[0028] Fig. 9 yes Figure 8 A cross-sectional view of the plugging member along line DD;

[0029] Fig.10 is a top view of the blocking member provided in Example 4 of the present application;

[0030] Fig.11 yes Fig.10 A cross-sectional view of the plugging member along line EE;

[0031] Fig.12 is a top view of the blocking member provided in Example 5 of the present application;

[0032] Fig.13 yes Fig.12 A cross-sectional view of the plugging member along line FF;

[0033] Fig.14 is a top view of the blocking member provided in Example 6 of the present application;

[0034] Fig.15 yes Fig.14 A cross-sectional view of the plugging member along line GG;

[0035] Fig.16 is a top view of the blocking member provided in Example 7 of the present application;

[0036] Fig.17 yes Fig.16 A cross-sectional view of the plugging member along line HH;

[0037] Fig.18 This is a cross-sectional view of an occluder provided in another embodiment of the present application housed in an outer sheath. DETAILED DESCRIPTION

[0038] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0039] The following descriptions of the embodiments are made with reference to the attached drawings to illustrate specific implementations of the present application. Directional terms mentioned in the present application, such as "top", "bottom", "front", "back", "left", "right", "inside", "outside", "side", etc., are only with reference to the directions of the attached drawings. Therefore, the directional terms used are for better and clearer explanation and understanding of the present application, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and should not be understood as a limitation on the present application.

[0040] In the description of the present application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", and "set on..." should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection; it can be a direct connection, or it can be an indirect connection through an intermediate medium, or it can be an internal connection between two elements.

[0041] In medical device technology, the proximal end of a medical device refers to the end closer to the operator, while the distal end of a medical device refers to the end farther from the operator. Axial refers to the direction of the central axis of the device, radial refers to the direction perpendicular to the axial direction and where the radius or diameter is located, and circumferential refers to the direction perpendicular to and surrounding the axial direction. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0042] See also Figure 1 , Figure 1 Schematic diagram of one of the blood vessels 200 in the body, the blood vessel 200 includes a main blood vessel 210 and multiple branch blood vessels 220, and the main blood vessel 210 and the multiple branch blood vessels 220 are connected. The blood in the main blood vessel 210 starts from the heart and flows to the multiple branch blood vessels 220. The main blood vessel 210 branches continuously and finally branches into a large number of capillaries, which are distributed to various tissues throughout the body. The inner diameter of the main blood vessel 210 is larger than the inner diameter of the branch blood vessel 220 of the next level, and the branch blood vessel 220 can also be the main blood vessel 210 of the multiple branch blood vessels 220 of the next level.

[0043] Although the functions and tissue structures of the blood vessel 200 are not completely the same, the blood vessel 200 basically includes multiple vascular membranes. Specifically, the blood vessel 200 includes a vascular intima 202, a vascular middle membrane 204, and a vascular adventitia. Vascular dissection is caused by the partial tearing of the vascular intima 202, thereby forming a rupture 203. The rupture 203 is impacted by blood, and blood continuously enters the gap between the vascular intima 202 and the vascular middle membrane 204 from the rupture 203. The vascular middle membrane 204 is gradually peeled off and expanded relative to the vascular intima 202, and the vascular intima 202 and the vascular middle membrane 204 are gradually separated. The gap between the vascular intima 202 and the vascular middle membrane 204 expands along the axial direction and radial direction of the blood vessel 200, thereby forming a vascular false lumen 205 and a vascular true lumen 206. The vascular true lumen 206 refers to the normal vascular lumen. If the blood vessel 200 is the body's aorta, since the aorta bears the pressure from the beating heart and has a huge blood flow, if the aortic dissection vessel media 204 and the vascular adventitia rupture, the situation is usually very critical and hemorrhagic shock will occur, resulting in severe lack of tissue perfusion.

[0044] See also Figures 1 to 5 , Figure 2 The occluder provided in one embodiment of the present application is positioned at Figure 1 In the structural schematic diagram of the blood vessel shown, the occluder 100 is located at the breach 203 of the blood vessel 200 , and the occluder 100 is used to block the breach 203 .

[0045] The occluder 100 includes an occluding member 10, which includes a first occluding portion 11 and a second occluding portion 15 connected along a central axis 102. The first occluding portion 11 is disposed at a distal end relative to the second occluding portion 15. Figure 5 The middle end refers to the end close to the top, opposite to the proximal end, which refers to the end close to the bottom.

[0046] The blocking member 10 is a deformable structure, which can be deformed at least in the radial direction and the axial direction. Figure 5 The middle direction is horizontal, and the axial direction is Figure 5 The middle refers to the vertical direction. The purpose of radial deformation is to allow the first sealing portion 11 and the second sealing portion 15 to shrink to a size smaller than the rupture 203, so as to penetrate the rupture 203 on the blood vessel 200. The purpose of axial deformation is to allow the first sealing portion 11 and the second sealing portion 15 to shrink elastically along the central axis 102 to clamp the vascular endothelium 202, so as to seal the rupture 203.

[0047] Specifically, the first sealing portion 11 and the second sealing portion 15 can be extended and shortened along the axial direction of the occluder 100. When the first sealing portion 11 and the second sealing portion 15 are extended axially, their axial dimensions increase and their radial dimensions decrease. When the first sealing portion 11 and the second sealing portion 15 are shortened axially, their axial dimensions increase and their radial dimensions decrease. In order to enable the occluder 100 to block the rupture 203 of the blood vessel 200, the radial dimensions of the first sealing portion 11 and the second sealing portion 15 are smaller than the diameter of the rupture 203 when the first sealing portion 11 and the second sealing portion 15 are in the axially extended state. In this way, the first sealing portion 11 passes through the rupture 203, and the first sealing portion 11 and the second sealing portion 15 are respectively located on both sides of the vascular endothelium 202, that is, the first sealing portion 11 is located in the false lumen 205 of the blood vessel, and the second sealing portion 15 is located in the true lumen 206 of the blood vessel. Then, the first sealing portion 11 and the second sealing portion 15 are axially shortened, and the first sealing portion 11 and the second sealing portion 15 can be elastically shortened along the central axis direction to be respectively attached to the two sides of the vascular endothelium 202, and the first sealing portion 11 and the second sealing portion 15 can clamp the vascular endothelium 202 on the opposite sides of the rupture 203 to achieve blocking of the rupture 203 on the blood vessel 200. Figure 2 The occluder 100 is shown in a state of sealing the tear 203 on the vascular endothelium 202 . At this time, the first sealing portion 11 and the second sealing portion 15 are respectively attached to the two sides of the vascular endothelium.

[0048] In some embodiments, see Figure 3 The blocking piece 10 also includes a waist 13, which is connected between the first blocking piece 11 and the second blocking piece 15. The radial dimensions of the first blocking piece 11 and the second blocking piece 15 are greater than the radial dimensions of the waist 13. The blocking piece 10 is integrally connected, that is, the first blocking piece 11, the waist 13 and the second blocking piece 15 are integrally connected, which can improve the strength of the blocking piece 10 and prevent the blocking piece 10 from being damaged or broken.

[0049] See also Figures 3 to 17 When the rupture of a blood vessel in the patient's body is close to the opening of a branch vessel, the occluder provided by the relevant technology generally has a double-layer disc-shaped structure. When the occluder blocks the rupture on the blood vessel, the disc-shaped structure is likely to partially or completely block the opening of the branch vessel, thereby causing blood vessel blockage and partial tissue necrosis.

[0050] In the occluder 100 provided in the present application, the first occluding portion 11 and / or the second occluding portion 15 include an avoidance section 104 and a peripheral section 105 in the circumferential direction, and the distance from the avoidance section 104 to the central axis 102 is less than the distance from the peripheral section 105 to the central axis 102. An additional blood flow channel is formed by the avoidance section 104 to prevent the first occluding portion 11 and / or the second occluding portion 15 from blocking the branch blood vessel, thereby ensuring smooth blood perfusion of the branch blood vessel. The blood in the branch blood vessel 220 can pass through the blood flow channel formed by the avoidance section, and the blood in the branch blood vessel 220 will not be blocked by the first occluding portion 11 and / or the second occluding portion 15, and the blood in the main blood vessel 210 can effectively flow from the blood flow channel formed by the avoidance section to the branch blood vessel 220.

[0051] In some embodiments, the first blocking portion 11 includes a first peripheral section and at least one first avoidance section in the circumferential direction, and the second blocking portion 15 includes a second peripheral section and at least one second avoidance section in the circumferential direction. In other examples, the first blocking portion 11 includes a first peripheral section and at least one first avoidance section in the circumferential direction, and the second blocking portion 15 includes a second peripheral section in the circumferential direction. In other examples, the first blocking portion 11 includes a first peripheral section in the circumferential direction, and the second blocking portion 15 includes a second peripheral section, i.e., at least one second avoidance section, in the circumferential direction. Since the first blocking portion 11 and / or the second blocking portion 15 are provided with an avoidance section 104 in the axial direction, from the top view or bottom view of the blocking member 10, the blocking member 10 is a disc-shaped structure with a notch, and the position of the notch on the disc-shaped structure is the position of the avoidance section 104. The disc-shaped structure can be changed according to the complex structure inside the blood vessel, and the blocking member 10 can also be other structures such as spherical, egg-shaped, pumpkin-shaped, lantern-shaped, elliptical, etc.

[0052] The surfaces of the first occluding portion 11 and the second occluding portion 15 of the occluder 100 include inner surfaces facing each other and outer surfaces facing away from each other, and at least one section of the outer surfaces of the first occluding portion 11 and the second occluding portion 15 is configured as an elastic extrusion portion 110 that bends toward each other from the inside to the outside in the radial direction. The elastic extrusion portion 110 applies elastic extrusion force to the vascular endothelium 202, thereby enhancing the sealing effect of the first occluding portion 11 and the second occluding portion 15 on the vascular endothelium 202, especially the avoidance section 104 on the vascular endothelium 202, and reducing or even preventing blood leakage caused by poor fit between the first occluding portion 11 and the second occluding portion 15 and the vascular endothelium 202.

[0053] The first blocking portion 11 and the second blocking portion 15 are a mesh structure formed by weaving elastic elongated pieces, the elastic elongated pieces are in the form of threads or lines, and the outer surfaces of the mesh structure formed by the first blocking portion 11 and the second blocking portion 15 can be bent toward each other to form an elastic extrusion portion 110, and the elastic extrusion portion 110 can be matched and abutted during the bending process to clamp the vascular endothelium 202. The elastic elongated pieces can be made of nickel, titanium or other suitable metal or alloy materials.

[0054] In some embodiments, the outer surface of the first blocking portion 11 is bent toward the second blocking portion 15, and the outer surface of the first blocking portion 11 forms an elastic pressing portion 110, and the first blocking portion 11 and the second blocking portion 15 can clamp the vascular endothelium 202. Or the outer surface of the second blocking portion 15 is bent toward the first blocking portion 11, and the outer surface of the second blocking portion 15 forms an elastic pressing portion 110, and the first blocking portion 11 and the second blocking portion 15 can clamp the vascular endothelium 202.

[0055] Since the mesh structure includes a plurality of meshes, the meshes are connected to the interior of the plugging member 10, and a flow-blocking film 107 can be provided on the outer wall and / or the inner wall of the plugging member 10. The flow-blocking film 107 can prevent blood from entering the interior of the plugging member 10 from the meshes, thereby preventing blood from passing through the crack 203, so as to achieve a better plugging effect, thereby preventing blood leakage. In addition, the provision of the flow-blocking film 107 can enhance the resistance between the flow-blocking film 107 and the vascular endothelium 202, prevent the occluding member 10 from moving relative to the vascular endothelium 202, thereby enhancing the firmness of the occluding member 10 on the vascular endothelium 202, and can also prevent the flow-blocking film from being torn to a certain extent.

[0056] The following describes the occluder 100 in detail by taking the example that the first blocking portion 11 includes a first outer peripheral section and a first avoidance section in the circumferential direction, and the second blocking portion 15 includes a second outer peripheral section and a second avoidance section in the circumferential direction.

[0057] In Example 1, Figure 4 and Figure 5 As shown, the avoidance section 104 includes a first avoidance section of the first blocking portion 11 and a second avoidance section of the second blocking portion 15, and the first avoidance section and the second avoidance section are arranged correspondingly, and the first avoidance section and the second avoidance section are radially concave in a groove shape, so that a first avoidance groove 112 is formed on the first blocking portion 11, and a second avoidance groove 152 is formed on the second blocking portion 15. At least one of the groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152 is an arc surface. In this example, the groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152 are both arc surfaces, and the arc surface can be considered to be formed by connecting one arc surface, and the arc surface can be considered to be formed by connecting more than two arc surfaces. Of course, the arc surface can be considered to be formed by connecting at least one arc and at least one plane, and there is no limitation here. Of course, the arc surface may not be an arc surface, but a curved surface with any curvature.

[0058] In this example, the groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152 are both formed by connecting an arc surface, and the axis of the arc surface is parallel to the central axis 102. The axes of the two arc surfaces are parallel to the central axis 102 of the occluder. The axis of the arc surface can be explained as follows: the radial section of the arc surface is a plane surrounded by the first arc line, and the perpendicular bisectors of the line connecting any two points on the first arc line intersect at the first intersection X, that is, there is a first intersection X on the inner side of the first arc line, and the distance from the first intersection X to any position of the first arc line is equal. The axis of the arc surface of the first avoidance groove 112 and the second avoidance groove 152 is a straight line passing through the first intersection X and parallel to the central axis 102 of the occluder. The groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152 are arc-shaped, which can conform to the complex structure of the blood vessel and facilitate the smooth flow of blood to the branch blood vessel.

[0059] Due to the squeezing effect of the elastic squeezing part 110, the edge of the first avoidance groove 112 can fit one side of the vascular endothelium 202, and the edge of the second avoidance groove 152 can fit the other side of the vascular endothelium 202, which can prevent blood from entering the interior of the occluding member 10 from the gaps between the first avoidance groove 112 and the vascular endothelium 202 and the second avoidance groove 152 and the vascular endothelium 202, so that the occluder 100 has the performance of preventing blood leakage. In addition, it can also prevent blood from forming thrombi in the peripheral area of ​​the waist 13, thereby avoiding blood vessel blockage.

[0060] The portion on the inner surface of the first sealing portion 11 for contacting the vascular endothelium 202 is called the first clamping surface 115, and the portion on the inner surface of the second sealing portion 15 for contacting the vascular endothelium 202 is called the second clamping surface 155. A clamping cavity 101 is formed between the first sealing portion 11 and the second sealing portion 15, and the first clamping surface 115 and the second clamping surface 155 are arranged around the clamping cavity 101. The clamping cavity 101 can also be considered as the lateral peripheral area of ​​the waist 13. A part of the clamping cavity 101 is formed by the first clamping surface 115 of the first sealing portion 11 being recessed inwardly along the direction of the central axis 102, and another part of the clamping cavity 101 is formed by the second clamping surface 155 of the second sealing portion 15 being recessed inwardly along the direction of the central axis 102, that is, the clamping cavity 101 is formed by the peripheral wall of the waist 13, the first clamping surface 115 of the first sealing portion 11, and the second clamping surface 155 of the second sealing portion 15. The clamping cavity 101 can also be understood as the first blocking portion 11 being bent from the inside to the outside in the radial direction at least partially toward the second blocking portion 15, and the second blocking portion 15 being bent from the inside to the outside in the radial direction at least partially toward the first blocking portion 11, so as to form a cavity in the lateral peripheral area of ​​the waist 13, which is the clamping cavity 101. The formation of the clamping cavity 101 can provide sufficient deformation space for the elastic deformation of the first blocking portion 11 and the second blocking portion 15, even if the first blocking portion 11 and the second blocking portion 15 generate greater stress after deformation, the clamping force of the first blocking portion 11 and the second blocking portion 15 on the vascular endothelium 202 can be improved, so that the occluder 100 is more firmly attached to the opposite sides of the vascular endothelium 202.

[0061] It can be understood that the greater the squeezing force of the elastic squeezing portion 110 between the first sealing portion 11 and the second sealing portion 15, the greater the deformation degree of the first sealing portion 11 and the second sealing portion 15, and thus the smaller the residual volume of the clamping cavity 101. When the squeezing force between the first sealing portion 11 and the second sealing portion 15 is the largest, the volume of the clamping cavity 101 is zero, that is, the first clamping surface 115 of the first sealing portion 11 and the second clamping surface 155 of the second sealing portion 15 are completely in contact with each other.

[0062] In Example 2, if Figure 6 and Figure 7 As shown, the structure of the sealing piece 10 of Example 2 is roughly the same as that of the sealing piece 10 of Example 1, and the difference between the sealing piece 10 of Example 2 and the sealing piece 10 of Example 1 mainly lies in that the avoidance section 104 of the first sealing portion 11 and the second sealing portion 15 of Example 2 is planar, and at least one of the groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152 is a plane or a plurality of connected planes, and the above-mentioned planes are parallel to the central axis 102 of the occluder 100.

[0063] In this example, the groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152 are both in a plane, so that a first cut surface 113 is formed on the first blocking portion 11, and a second cut surface 153 is formed on the second blocking portion 15. The first cut surface 113 and the second cut surface 153 are parallel to the central axis 102 of the occluder. Compared with the occluder 10 of Example 1, the structure of the occluder 10 in Example 2 is simplified.

[0064] Due to the squeezing effect of the elastic squeezing part 110, the edge of the first cut surface 113 can fit one side of the vascular endothelium 202, and the edge of the second cut surface 153 can fit the other side of the vascular endothelium 202, which can prevent blood from flowing into the interior of the occluding device 10 through the gap between the first cut surface 113 and the second avoidance groove 152, so that the occluder 100 has the performance of preventing blood leakage.

[0065] In Example 3, Figure 8 and Fig. 9 As shown, the structure of the blocking member 10 of Example 3 is roughly the same as that of the blocking member 10 of Example 1. The difference between the blocking member 10 of Example 3 and that of Example 1 is mainly that the inner surface of the first blocking portion 11 forms a first blocking flange 114, and the inner surface of the second blocking portion 15 forms a second blocking flange 154; the first blocking flange 114 and the second blocking flange 154 are used to abut against both sides of the vascular intima 202. Specifically, the first blocking flange 114 is connected to the groove surface of the first avoidance groove 112, and the second blocking flange 154 is connected to the groove surface of the second avoidance groove 152. When the occluder 100 is implanted in the rupture of the blood vessel, the first blocking flange 114 and the second blocking flange 154 are abutted.

[0066] The first blocking flange 114 and the second blocking flange 154 can be considered as extensions of the groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152. By providing the first blocking flange 114 and the second blocking flange 154, the groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152 are larger in area, and when the squeezing effect of the elastic squeezing part 110 makes the outer peripheral part of the first blocking part 11 and the outer peripheral part of the second blocking part 15 abut against each other, the first blocking flange 114 and the second blocking flange 154 clamp the vascular endothelium 202, and the first blocking flange 114 and the second blocking flange 154 directly block the gap at the joint of the first avoidance groove 112 and the second avoidance groove 152, thereby preventing blood from entering the clamping cavity 101 and preventing blood from forming a thrombus in the clamping cavity 101.

[0067] See also Figure 7 and Fig. 9 The difference between the two embodiments is that Figure 7In the embodiment shown, when not implanted in the body, the blocking member 10 is in a natural state outside the body, and the left side of the clamping cavity 101 has an opening connected to the outside world. After implantation in the body, the opening on the left side of the clamping cavity 101 can be closed by pulling the first blocking portion 11 and the second blocking portion 15 closer. Fig. 9 In the illustrated embodiment, when not implanted in the body, the blocking member 10 is in a natural state outside the body, and there is no opening connected to the outside world on the left side of the clamping cavity 101. That is to say, after the blocking member 10 is implanted in the body, even if no external force is applied to bring the first blocking portion 11 and the second blocking portion 15 closer together, the blocking member 10 can maintain the closure of the clamping cavity 101 by relying on its own elastic force, thereby providing a better sealing effect, and can also maintain the sealing effect of the clamping cavity 101 with a smaller external force, so that the blocking member 10 has a better sealing effect on the crack 203 and a more stable sealing state.

[0068] In Example 4, Fig.10 and Fig.11 As shown, the structure of the sealing piece 10 of Example 4 is substantially the same as that of the sealing piece 10 of Example 1, and the difference between the sealing piece 10 of Example 4 and the sealing piece 10 of Example 1 mainly lies in that the first clamping surface 115 and the second clamping surface 155 can abut against each other, and the abutting area of ​​the first clamping surface 115 and the second clamping surface 155 of the sealing piece 10 of Example 4 is much larger than the abutting area of ​​the first clamping surface 115 and the second clamping surface 155 of the sealing piece 10 of Example 1.

[0069] In Example 5, Fig.12 and Fig.13 As shown, the structure of the blocking piece 10 of Example 5 is roughly the same as that of the blocking piece 10 of Example 1, and the difference between the blocking piece 10 of Example 5 and the blocking piece 10 of Example 1 mainly lies in that the first avoidance section 1041 of the first sealing portion 11 and the second avoidance section 1042 of the second sealing portion 15 are staggered, so that the structures of the first sealing portion 11 and the second sealing portion 15 are more diverse to adapt to the complex structure inside the blood vessel.

[0070] Specifically, the groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152 are both arc surfaces, and the axes of the two arc surfaces are parallel to the central axis 102 of the occluder. The arc surface of the first avoidance groove 112 intersects with a radial section thereof to form a second arc line, and the perpendicular bisector of a line formed by connecting any two points on the second arc line intersects at the second intersection Y, and the distance from the second intersection Y to any position of the second arc line is equal, and the axis of the arc surface of the first avoidance groove 112 is a straight line passing through the second intersection Y and parallel to the central axis 102 of the occluder. The arc surface of the second avoidance groove 152 intersects with a radial section thereof to form a third arc line, and the perpendicular bisector of a line formed by connecting any two points on the third arc line intersects at the third intersection Z, and the distance from the third intersection Z to any position of the third arc line is equal, and the axis of the arc surface of the second avoidance groove 152 is a straight line passing through the third intersection Z and parallel to the central axis 102 of the occluder.

[0071] In this example, the projections of the groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152 and the central axis 102 of the occluder on a plane perpendicular to the central axis 102 of the occluder are three points, and the angle A1 formed by the line connecting the three points is 180°. In other examples, the angle A1 can also be other angles, and the range of A1 is between 0° and 360°. Among them, when A1 = 0° or when A1 = 360°, the structure of the occluding member 10 in Example 5 is the same as the structure of the occluding member 10 in Example 1.

[0072] In Example 6, Fig.14 and Fig.15 As shown, the structure of the blocking piece 10 of Example 6 is substantially the same as that of the blocking piece 10 of Example 5, and the main difference between the blocking piece 10 of Example 6 and the blocking piece 10 of Example 5 is that the first avoidance section 1041 of the first blocking portion 11 and the second avoidance section 1042 of the second blocking portion 15 of Example 6 are planar, so that a first section 113 is formed on the first blocking portion 11, and a second section 153 is formed on the second blocking portion 15, and the first section 113 and the second section 153 are parallel to the central axis 102 of the occluder.

[0073] In this example, the vertical line of the first section 113 and the vertical line of the second section 153 form an angle A2, and A2 is 180°. In other examples, the angle A2 can also be other angles, and the range of A2 is between 0° and 360°. Among them, when A2=0° or when A2=360°, the structure of the blocking member 10 in Example 6 is the same as the structure of the blocking member 10 in Example 2.

[0074] In Example 7, Fig.16 and Fig.17As shown, the structure of the plugging member 10 of Example 7 is substantially the same as that of the plugging member 10 of Example 5, and the difference between the plugging member 10 of Example 7 and the plugging member 10 of Example 5 is mainly that at least one of the groove surface of the first avoidance groove 112 and the groove surface of the second avoidance groove 152 is an arc surface. More specifically, one of the first avoidance section 1041 of the first blocking portion 11 and the second avoidance section 1042 of the second blocking portion 15 is concave in the radial direction to form a groove shape, and the other is a plane shape, so that the first blocking portion 11 or the second blocking portion 15 forms an avoidance groove, and the other forms a cut surface.

[0075] In this example, the first avoidance section 1041 of the first blocking portion 11 is radially concave to form a first avoidance groove 112, and the second avoidance section 1042 of the second blocking portion 15 forms a second cut surface 153. In other examples, the second avoidance section 1042 of the second blocking portion 15 is radially concave to form a second avoidance groove 152, and the first avoidance section 1041 of the first blocking portion 11 forms a first cut surface 113.

[0076] The above examples discuss the case where the edge of the first sealing portion 11 includes a first avoidance section 1041 in the circumferential direction, and the edge of the second sealing portion 15 includes a second avoidance section 1042 in the circumferential direction. In other examples, according to actual conditions, that is, according to the branching direction of the blood vessel, the edge of the first sealing portion 11 includes multiple first avoidance sections 1041 in the circumferential direction, and the edge of the second sealing portion 15 includes multiple second avoidance sections 1042 in the circumferential direction, so that the circumferential inward concave of the first sealing portion 11 or the second sealing portion 15 forms multiple avoidance grooves.

[0077] See also Figure 2 and Fig.18 The occluding member 10 defines a central axis 102, and the occluding member 10 is configured to contract radially inward relative to the central axis 102, and can also be configured to expand radially outward relative to the central axis 102. The occluding member 10 in the contracted state can be more conveniently inserted into the outer sheath 120 (the outer sheath 120 is the medium for the occluding device 100 to enter the heart), so as to be conveniently delivered into the human body through the sheath.

[0078] In the contracted state, the plugging member 10 is movably accommodated in the outer sheath 120. Since the plugging member 10 is elastic and can contract, when the plugging member 10 is accommodated in the outer sheath 120, under the action of the squeezing force of the inner wall of the outer sheath 120, the plugging member 10 is axially extended. Since the radial dimension of the waist 13 is smaller than the radial dimension of the first plugging portion 11 and the second plugging portion 15, the waist 13 is not squeezed by the inner wall of the outer sheath 120, that is, the first plugging portion 11 and the second plugging portion 15 are squeezed and axially extended. When the plugging member 10 passes through the outer sheath 120 and reaches the vicinity of the cleft 203, the first plugging portion 11 is transported to the vascular false lumen 205, and the plugging member 10 can be converted from the contracted state to the expanded state, and the first plugging portion 11 and the second plugging portion 15 are pressed against each other to clamp the vascular endothelium 202 on opposite sides of the cleft 203.

[0079] The blocking member 10 may be converted to the expanded state when it extends out of the outer sheath 120 and expands radially due to the removal of the squeezing force of the inner wall of the outer sheath 120 , or the blocking member 10 may expand radially under human control after extending out of the outer sheath 120 .

[0080] like Fig.18 As shown, the blocking member 10 is in an axially extended state inside the outer sheath 120, and the first blocking portion 11 and the second blocking portion 15 are in an unlocked state. When the blocking member 10 is pushed out of the outer sheath 120, the first blocking portion 11 and the second blocking portion 15 can be operated to approach each other. Specifically, the occluder 100 also includes an operating assembly 20, the operating assembly 20 includes a first operating member 22 and a second operating member 24 movably sleeved on the first operating member 22, the first operating member 22 is inserted into the interior of the blocking member 10, the first operating member 22 is detachably connected to the distal end of the first blocking portion 11, and the second operating member 24 is detachably connected to the proximal end of the second blocking portion 15. When the distal ends of the first operating member 22 and the distal ends of the second operating member 24 are moved away from each other, the first blocking portion 11 and the second blocking portion 15 can be driven to stretch along the axial direction, so that the first blocking portion 11 and the second blocking portion 15 are in a contracted state. When the distal ends of the first operating member 22 and the second operating member 24 are driven to approach each other, the first sealing portion 11 and the second sealing portion 15 can be driven to shorten axially, so that the first sealing portion 11 and the second sealing portion 15 are in an expanded state. The first sealing portion 11 and the second sealing portion 15 in the expanded state are in contact with each other, thereby clamping the vascular endothelium 202 on the opposite sides of the rupture 203.

[0081] In some embodiments, the second operating member 24 of the first operating member 22 can be a slender soft steel cable or steel tube, which is soft and can be bent and deformed, but has a certain degree of support, so as to push the first blocking part 11 and the second blocking part 15 away.

[0082] The first blocking portion 11 and the second blocking portion 15 are close to each other, and the blocking member 10 is in an expanded state in the radial direction. The first blocking portion 11 and the second blocking portion 15 can be locked with each other, so that the blocking member 10 is kept in a Figure 3 The first sealing portion 11 and the second sealing portion 15 are separated from each other, and the sealing member 10 is in a contracted state in the radial direction. The first sealing portion 11 and the second sealing portion 15 can be unlocked to keep the sealing member 10 in the radial direction. Fig.18 Shown in radially contracted state.

[0083] Specifically, the occluder 100 further includes a locking assembly 30, which includes a connecting member 32 and a locking member 34. The connecting member 32 is fixedly connected to the proximal end of the second blocking portion 15, and the proximal end of the connecting member 32 is detachably connected to the tubular second operating member 24, and the first operating member 22 is slidably arranged inside the second operating member 24. The distal end of the locking member 34 is connected to the distal end of the first blocking portion 11, and the proximal end of the locking member 34 is detachably connected to the first operating member 22. At least part of the locking member 34 is elastic, and the locking member 34 is connected to the connecting member 32 through elastic deformation to lock the relative position of the first blocking portion 11 and the second blocking portion 15.

[0084] The locking member 34 may be elastic as a whole, that is, the locking member 34 may be elastically deformed as a whole, or a part of the locking member 34 may be elastic and the other part may be rigid, that is, a part of the locking member 34 may be elastically deformed. When the locking member 34 is subjected to an external radial / axial extrusion force, the locking member 34 may reduce its radial / axial dimensions due to elastic deformation; when the locking member 34 removes the external radial / axial extrusion force, the locking member 34 may expand its radial / axial dimensions due to elastic deformation. For another example, when the locking member 34 is subjected to an external radial / axial pulling force, the locking member 34 may expand its radial / axial dimensions due to elastic deformation; when the locking member 34 removes the external radial / axial pulling force, the locking member 34 may reduce its radial / axial dimensions due to elastic deformation.

[0085] In some embodiments, the locking member 34 includes a first connecting portion 341 and a second connecting portion 342 disposed at opposite ends thereof, and a positioning portion 343 connected between the first connecting portion 341 and the second connecting portion 342, wherein the first connecting portion 341 is fixedly connected to the distal end of the first blocking portion 11, and the second connecting portion 342 is fixedly connected to the distal end of the first operating member 22, and the positioning portion 343 is an elastic structure that can be elastically deformed, that is, the positioning portion 343 can expand or reduce the radial / axial size due to elastic deformation. The first operating member 22 can move axially relative to the second operating member 24, and can adjust the relative distance between the first blocking portion 11 and the second blocking portion 15, and can also adjust the relative distance between the connecting member 32 and the locking member 34.

[0086] The connecting member 32 is provided with a receiving inner cavity 322 and a connecting hole 324 communicating with the receiving inner cavity 322 near its distal end. The inner diameter of the receiving inner cavity 322 is larger than the aperture of the connecting hole 324. The first operating member 22 pulls the locking member 34 to move toward the proximal end. The outer portion of the positioning portion 343 is squeezed by the side wall of the connecting hole 324. The positioning portion 343 can shrink radially through elastic deformation, thereby passing through the connecting hole 324. The portion of the positioning portion 343 passing through the connecting hole 324, that is, the portion of the positioning portion 343 received in the receiving inner cavity 322, is relieved of the squeezing from the side wall of the connecting hole 324, and the positioning portion 343 can expand radially in the receiving inner cavity 322.

[0087] When the positioning portion 343 completely enters the receiving inner cavity 322, that is, the distal end of the positioning portion 343 enters the receiving inner cavity 322, after that, the radial squeezing force of the positioning portion 343 is released, and the radial dimension of the positioning portion 343 expands to be larger than the aperture of the connecting hole 324, the positioning portion 343 and the connecting member 32 are locked, thereby realizing the locking of the first blocking portion 11 and the second blocking portion 15. The degree to which the positioning portion 343 is received in the receiving inner cavity 322 can adjust the clamping force of the first blocking portion 11 and the second blocking portion 15, that is, when the positioning portion 343 completely enters the receiving inner cavity 322, the clamping force of the first blocking portion 11 and the second blocking portion 15 is the largest. The clamping force of the first sealing part 11 and the second sealing part 15 can also be reflected by the volume of the lateral clamping cavity 101 of the waist 13. The volume of the clamping cavity 101 gradually decreases, and the clamping force of the first sealing part 11 and the second sealing part 15 gradually increases. That is, when the clamping cavity 101 is zero, the clamping force of the first sealing part 11 and the second sealing part 15 is the largest.

[0088] In some embodiments, the locking assembly 30 further includes a connecting cylinder 35, through which the distal end of the first operating member 22 is detachably connected to the proximal end of the locking member 34. Specifically, the distal end of the connecting cylinder 35 is provided with a connecting groove 351, and the proximal end of the locking member 34 is fixed in the connecting groove 351, that is, the second connecting portion 342 is fixed in the connecting groove 351, and the second connecting portion 342 can be fixed in the connecting groove 351 by, but not limited to, clamping, welding or other methods. The proximal end of the connecting cylinder 35 is provided with a first threaded hole 353, the inner wall of the first threaded hole 353 is provided with an internal thread, and the outer wall of the first operating member 22 near the distal end is provided with an external thread, and the first operating member 22 is detachably connected to the connecting cylinder 35 by screwing the internal thread and the external thread. When the first operating member 22 and the connecting cylinder 35 are separated, the first operating member 22 can be released from the connecting cylinder 35 by simply rotating the first operating member 22.

[0089] In some embodiments, at least a portion of the connecting member 32 exposed outside the second blocking portion 15 is provided with an external thread, a second threaded hole 242 is provided at a distal end of the second operating member 24, an internal thread is provided on the inner wall of the second threaded hole 242, and the second operating member 24 is detachably connected to the connecting member 32 by screwing the internal thread and the external thread. When the second operating member 24 and the connecting member 32 are separated, the second operating member 24 can be released from the connecting member 32 by simply rotating the second operating member 24.

[0090] When the occluder is released to the target position, the first sealing part 11 and the second sealing part 15 are locked, that is, the first sealing part 11 and the second sealing part 15 clamp the vascular endothelium 202 on opposite sides of the rupture 203, the first operating member 22 can be released from the connecting tube 35, the second operating member 24 can be released from the connecting member 32, and then the first operating member 22 and the second operating member 24 are withdrawn from the human body.

[0091] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other, and any combination of features in different embodiments is also within the scope of protection of the present application. In other words, the multiple embodiments described above can also be arbitrarily combined according to actual needs. It should be noted that all the above-mentioned drawings are exemplary illustrations of the present application and do not represent the actual size of the product. And the dimensional ratio relationship between the components in the drawings is not intended to limit the actual product of the present application. The description of the above embodiments is only used to help understand the method and core idea of ​​the present application. The scope of protection of the present application is not limited to this. Any technician familiar with the art can easily think of changes or replacements within the technical scope disclosed in the present application, which should be covered within the scope of protection of the present application. In summary, the content of this specification should not be understood as a limitation on the present application.

Claims

1. An occluder, characterized in that: It comprises a first blocking part and a second blocking part connected along the central axis direction, wherein the first blocking part and the second blocking part can elastically contract along the central axis direction to clamp the vascular endothelium; The first blocking portion and / or the second blocking portion comprises an outer peripheral section and an avoidance section in the circumferential direction, and the distance between the avoidance section and the central axis is smaller than the distance between the outer peripheral section and the central axis; The surfaces of the first blocking portion and the second blocking portion include outer surfaces facing away from each other, and at least one section of the outer surfaces of the first blocking portion and the second blocking portion along the radial direction from the inside to the outside is configured as an elastic pressing portion bent toward each other.

2. The occluder according to claim 1, characterized in that: The avoidance section is concave in the radial direction and is groove-shaped, so that a first avoidance groove is formed on the first blocking portion, and a second avoidance groove is formed on the second blocking portion.

3. The occluder according to claim 2, characterized in that: At least one of the groove surface of the first avoidance groove and the groove surface of the second avoidance groove is a curved surface.

4. The occluder according to claim 3, characterized in that: At least one of the groove surface of the first avoidance groove and the groove surface of the second avoidance groove is an arc surface, and the axis of the arc surface is parallel to the central axis of the occluder.

5. The occluder according to claim 2, characterized in that: At least one of the groove surface of the first avoidance groove and the groove surface of the second avoidance groove is a plane or a plurality of connected planes, and the plane is parallel to the central axis of the occluder.

6. The occluder according to claim 1, characterized in that: The avoidance section of the first blocking portion and the avoidance section of the second blocking portion are offset from each other in the circumferential direction.

7. The occluder according to claim 1, characterized in that: The avoidance section is planar.

8. The occluder according to claim 1, characterized in that: The inner surface of the first sealing portion forms a first sealing flange, and the inner surface of the second sealing portion forms a second sealing flange; the first sealing flange and the second sealing flange are used to abut against two sides of the vascular endothelium.

9. The occluder according to any one of claims 1 to 8, characterized in that: The portion on the inner surface of the first sealing portion that is used to contact the vascular endothelium is called a first clamping surface, and the portion on the inner surface of the second sealing portion that is used to contact the vascular endothelium is called a second clamping surface. The first clamping surface and the second clamping surface can be in contact with each other.

10. The occluder according to any one of claims 1 to 8, characterized in that: The portion of the inner surface of the first blocking portion that is used to contact the vascular endothelium is called a first clamping surface, and the portion of the inner surface of the second blocking portion that is used to contact the vascular endothelium is called a second clamping surface; A clamping cavity is formed between the first blocking portion and the second blocking portion, and the first clamping surface and the second clamping surface are arranged around the clamping cavity.

11. The occluder according to claim 1, characterized in that: The occluder also includes an operating component, which includes a first operating member and a second operating member movably mounted on the first operating member, the first sealing portion is arranged at a distal end relative to the second sealing portion, the first operating member is detachably connected to the distal end of the first sealing portion, the second operating member is detachably connected to the proximal end of the second sealing portion, and the distal ends of the first operating member and the second operating member are close to each other so that the first sealing portion and the second sealing portion are in contact with each other.

12. The occluder according to claim 11, characterized in that: The occluder also includes a locking assembly, which includes a connecting piece and a locking piece. The connecting piece is fixedly connected to the proximal end of the second occluding part, the proximal end of the connecting piece is detachably connected to the second operating piece, the distal end of the locking piece is connected to the distal end of the first occluding part, the proximal end of the locking piece is detachably connected to the first operating piece, at least part of the locking piece is elastic, and the locking piece is connected to the connecting piece by elastic deformation to lock the relative positions of the first occluding part and the second occluding part.

13. The occluder according to claim 12, characterized in that: The connecting piece is provided with a receiving inner cavity and a connecting hole connected with the receiving inner cavity. The inner diameter of the receiving inner cavity is larger than the hole diameter of the connecting hole. The locking piece includes an elastic positioning portion. The positioning portion can be radially contracted and penetrated through the connecting hole. The positioning portion can be radially expanded in the receiving inner cavity, thereby realizing the locking of the positioning portion and the connecting piece.

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